Z-1332-04

Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options

Name: Z-1332-04 Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options
Creator: Advanced Bionics Corporation
Published: 2004-07-27
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2004-07-27 / Terminated

FDA source

Advanced Bionics Corporation began a recall of Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options on 2004-07-27. The reason FDA records is "Battery pack may overheat and cause patient burns". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1332-04
Status: Terminated
Initiated: 2004-07-27
Posted: 2004-08-10
Terminated: 2012-03-23
Recalling firm: Advanced Bionics LLC
Product: Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
Product code: MCM Implant, Cochlear
Reason for recall: Battery pack may overheat and cause patient burns.
FDA root cause: Other
Action: Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005
Quantity in commerce: 2458
Distribution: Nationwide and Canada
Product codes and lots: All Codes.

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)